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The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

Information source: China Medical University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemic Stroke

Intervention: Cilostazol (Drug); placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: China Medical University Hospital

Official(s) and/or principal investigator(s):
Chung Y. Hsu, MD. Ph.D., Principal Investigator, Affiliation: China Medical University Hospital

Summary

The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan.

Clinical Details

Official title: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The primary endpoint for this study is slowdown of PAD progression based on ABI.

Secondary outcome: Carotid intima-media thickness

Detailed description: One thousand patients will be randomized to take cilostazol (500 patients) or placebo (500 patients) in parallel groups. Patients will be screened and evaluated on Visits 1 to assess their eligibility prior to randomization. The treatment period (Visit 1-6) will last 12 months and the patient will receive initial and follow-up evaluation (section 4. 5) including history and physical examinations, and baseline and end of treatment ABI and carotid IMT assessments. Vascular events and death as well as adverse events including bleeding complications will also be recorded at intervals as detailed in section 4. 5.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patients, age ≧50 years; for female patients, postmenopausal (defined

as at least 2 years without menses) has to be confirmed.

- Ischemic stroke or transient ischemic attack patients who have been taking aspirin

100 mg, QD

- Neurologically and clinically stable at inclusion

- PAD (i. e. ankle-brachial index or ABI <1. 0)

Exclusion Criteria:

- Patients unable to give informed consent

- Patients with history of any type of hemorrhagic stroke (intracerebral

hemorrhage,subarachnoid hemorrhage, or others)

- Modified Rankin Scale >4

- Patients with history of dementia requiring institutional care

- Known brain tumor

- Known anemia (defined as hemoglobin <10. 0 g/dL)

- Known thrombocytopenia (defined as platelet count below 100,000/cm3)

- AST or ALT > 3 x Upper Normal Limit

- Calculated creatinine clearance < 30 ml/min according to the Copckroft formula)

- Known hemostasis or coagulation disorder

- Congestive heart failure, defined as a previous definitive diagnosis, or present

symptoms of at least Category II of the NYHA classification system for CHF

- Revascularization of the lower limb arteries including bypass surgery, endovascular

procedures

- Symptomatic PAD requiring treatment with cilostazol

- Known stenosis of the upper limb arteries that may affect the documentation of ABI

- Patients with known hypersensitivity to cilostazol

Locations and Contacts

Additional Information

Starting date: September 2010
Last updated: September 30, 2013

Page last updated: August 23, 2015

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